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EP1673119A1 - Ampoule pour un injecteur sans aiguille - Google Patents

Ampoule pour un injecteur sans aiguille

Info

Publication number
EP1673119A1
EP1673119A1 EP04787017A EP04787017A EP1673119A1 EP 1673119 A1 EP1673119 A1 EP 1673119A1 EP 04787017 A EP04787017 A EP 04787017A EP 04787017 A EP04787017 A EP 04787017A EP 1673119 A1 EP1673119 A1 EP 1673119A1
Authority
EP
European Patent Office
Prior art keywords
ampoule
protective cap
ampoule according
distal
nozzle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
EP04787017A
Other languages
German (de)
English (en)
Inventor
Peter Eichhorst
Wolfgang Heidl
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Primojex GmbH
Original Assignee
Primojex GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Primojex GmbH filed Critical Primojex GmbH
Publication of EP1673119A1 publication Critical patent/EP1673119A1/fr
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/065—Rigid ampoules, e.g. glass ampoules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3118—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
    • A61M2005/312—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic

Definitions

  • the invention relates to an ampoule for a needleless injector, which comprises an ampoule body which forms an interior for receiving a product to be injected, and ' a nozzle arrangement at the distal end of the ampoule body and at the proximal end ' . of the ampoule body ' an actuating device ' for. Applying comprises the product in the vial body 'with a pressure.
  • Ampoules of the generic type are known. These are in. Needle-free injectors are used, by means of which a product to be injected is applied under pressure to a tissue area, so that this enters the tissue due to the pressure. Such needleless injectors have a 'receiving area for one, filled, the contained product to be injected ampoule, an actuator to-r impingement of the product at a pressure so that the product through a Düseanssen exits and enters the desired tissue portions.
  • the pressure can be applied here by a trigger element that can be pretensioned against the force of a spring element or by an external pressure medium.
  • Injectable products are understood to mean in particular liquids, for example solutions, suspensions or dispersions, which contain an active substance. Active substances can be pharmacologically active substances for treating the human or animal body or substances for diagnosis or cosmetic use. Furthermore, the injectable products can also be used to supply active substances in plants.
  • Ampoules of the generic type are known, for example, from EP 0 518 561 A1, EP 0 427 457 B1, EP 0 856 175 Bl and EP 0 792 174 Bl.
  • the invention has the object of providing an ampoules ⁇ le of the generic type to create, which is characterized by a simple structure, a simple filling bility and universal applicability.
  • the object is achieved by an ampoule with the features mentioned in claim 1.
  • Characterized in that the nozzle arrangement of the ampoule is associated with a protective cap, "defined whose distal area Defi- from a proximal region of the protective cap is removable, it is advantageously possible beglal- len the ampoule with a product to be injected to. And these filled ampoule for a to provide long-term storage is available.
  • the nozzle assembly associated protective cap closing a dense comparison of the interior of the ampoule body ensured ⁇ so that on the one hand ⁇ impurities penetration 'of Ver. germs or the like in the inner space and on the other hand volatilization of the product to be injected from the interior is prevented.
  • the vial is always in a simple manner for their intended purpose provided USAGE ⁇ dung available.
  • the distal area and the proximal area of the protective cap are connected via a S.oll break point.
  • a S.oll break point In addition to simple, defined separation of the distal region of the 'cap by this target is achieved Br ⁇ chstelle a tamper simultaneously. If the predetermined breaking point is intact, it can be assumed that the ampoule is unused or manipulated . tions of any kind are excluded.
  • the proximal area of the protective cap forms a ring anchor for the ampoule.
  • the remaining in the ampoule body proximal region of the protective cap has a protective function, in particular in 'the use of the vial i a needleless injector does.
  • the pressures occurring in the ampoule body during the needleless injection can thus differ from the ring anchor the proximal region of the protective cap that forms it, so that the ampoule body can not be ruptured or the like in the region of the nozzle arrangement.
  • the proximal region forms a self-adjusting guide for the ampoule in the needleless injector.
  • the ampoule in particular the ampoule body, the nozzle arrangement, the protective cap and the actuating device consist of materials which are suitable for long-term storage of the products to be injected, in particular medicaments.
  • the ampoule body preferably made of glass, in particular borosilicate glass, the protective cap and the domestic product with the Pro ⁇ the actuating device of butyl rubber and the outlet nozzle of the nozzle assembly of surgical grade steel coming into contact portion.
  • the dimensions and shape of the ampoule are based on known dimensions and shapes of fillable storage containers for disposable syringes or the like. This advantageously ensures that systems for filling the ampoules in known filling ⁇ such as ready-to-fill systems, can be used.
  • Figure 1 is a sectional view of an ampoule for a needleless injector
  • Figure 2 shows an enlarged detail of a nozzle arrangement of the ampoule
  • Figure 3 is an overall view of a needleless Injek ⁇ tors with "inserted ampoule.
  • FIG. 1 shows an ampoule, generally designated 10, for a needleless injector.
  • the structure and function of needleless injectors are generally known, so that they are not dealt with in detail in the present description.
  • the ampoule 10 comprises an ampoule body 12, which forms an interior 14 for receiving an injectable product.
  • the ampoule body 12 is essentially designed as a rotationally symmetrical hollow cylinder.
  • the ampoule 10 has a nozzle arrangement 16 and an actuating device 18.
  • the nozzle arrangement 16 is covered by a protective cap 20.
  • the interior 14 is delimited at its proximal end by a plug 22 which is connected to a piston rod 24.
  • the plug 22 is made of for example from Butylgu mi, while the piston rod 24 consists for example of a plastic.
  • the plug 22 is sealingly guided in the ampoule body 12, so that a product to be injected, which is introduced into the interior 14, is hermetically sealed.
  • the plug 22 and the piston rod 24 form the actuating device 18.
  • the interior 14 is also closed by the protective cap 20, which has a first region 26 and a second region 28.
  • the areas 26 and 28 are connected to one another by a web 30.
  • the area 28 of the protective cap 20 is placed on the ampoule body 12, snapped on or the like.
  • the area 28 of the protective cap 20 and the ampoule body 12 have corresponding corresponding shape features.
  • a predetermined breaking point 32 is arranged between the web 30 and the area 28 of the protective cap 20.
  • the ampoule 10 shown in FIG. 1 has the following function:
  • the ampoule 10 is filled in a manner known per se by means of an automatic filling system, for example a ready-to-fill filling system, with the product to be injected, for example a solution, dispersion, suspension or the like containing a pharmacologically active substance, and with the plug 22 and the piston rod 24 closed and completed.
  • the interior 14 thus contains a defined amount of a product to be injected.
  • the nozzle arrangement 16 is protected by the protective cap 20, at the same time preventing the product from escaping from the interior 14.
  • the ampoule 10 is then sterile packaged in a known manner in a blister pack. By. Long-term storage is possible in the choice of materials and packaging of the ampoule 10.
  • Figure 2 shows an enlarged detail of the ampoule 10, wherein like parts are provided as in figure 1 with the same reference numerals and will not again tert erläu ⁇ .
  • the ampoule is loaded a needleless injector • in an indicated here housing 34 10 degrees.
  • the housing 34 forms a Publ ⁇ voltage of 36 through which the cap 20 of the vial can be guided 10th
  • a diameter of the Publ ⁇ voltage 36 greater than an outer diameter of region 26 of the protective cap 20th
  • the ampoule body 12 has an d.istal opening 38 in which a nozzle 40 is arranged.
  • the nozzle 40 is glued into the opening 38, for example, by means of a UV-curable adhesive.
  • the nozzle 40 consists example ⁇ , from surgical stainless steel.
  • FIG. 3 shows an overall arrangement in which the ampoule 10 is inserted into a needleless injector 44.
  • the pre-filled or 'filled ampoule 10 can be used in disposable or multiple injectors.
  • the ampoule 10 is inserted into the housing 34 of the needleless injector 44.
  • the region 28 of the cap 20 serves as adjustment stop in the housing 34.
  • the housing 34 may be formed ehrtei- lig and also receives a tripping SETUP 'ung 46.
  • This has a bolt 50 that can be preloaded against the force of a spring element 48.
  • the preloaded bolt 50 can be accelerated against the piston rod 24 (FIG. 1) by a trigger 52, so that the function of the needleless injector 44 known per se occurs.
  • the piston rod 24 is accelerated, so that the product to be injected in the interior 14 is pressurized via the stopper 22.
  • the product is - after tearing off the area 26 or the web 30 of the protective cap 20 - free nozzle hole 42 is expelled from the interior 14, so that the product at the required pressure and exits' can be administered, for example, needle-free subcutaneous.
  • the area 28 of the protective cap 20, which surrounds the ampoule body 12 like the ring anchor, ensures that the pressure which arises in this case does not lead to the ampoule body 12 bursting.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

Ampoule pour un injecteur sans aiguille, qui comporte un corps formant un espace interne destiné à contenir un produit à injecter, un dispositif buse situé à l'extrémité distale du corps d'ampoule et un dispositif d'actionnement situé à l'extrémité proximale du corps d'ampoule et destiné à agir par pression sur le produit situé dans le corps de l'ampoule. Le dispositif buse (16) est pourvu d'un couvercle protecteur (20) dont la partie distale (26) peut être définitivement séparée d'une partie proximale (28).
EP04787017A 2003-10-08 2004-09-21 Ampoule pour un injecteur sans aiguille Ceased EP1673119A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE2003147379 DE10347379A1 (de) 2003-10-08 2003-10-08 Ampulle für einen nadellosen Injektor
PCT/EP2004/010784 WO2005032625A1 (fr) 2003-10-08 2004-09-21 Ampoule pour un injecteur sans aiguille

Publications (1)

Publication Number Publication Date
EP1673119A1 true EP1673119A1 (fr) 2006-06-28

Family

ID=34399469

Family Applications (1)

Application Number Title Priority Date Filing Date
EP04787017A Ceased EP1673119A1 (fr) 2003-10-08 2004-09-21 Ampoule pour un injecteur sans aiguille

Country Status (3)

Country Link
EP (1) EP1673119A1 (fr)
DE (1) DE10347379A1 (fr)
WO (1) WO2005032625A1 (fr)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE69117464T2 (de) * 1990-09-18 1996-10-10 Barry Farris Kolbenlose Spritze
ATE195916T1 (de) * 1996-04-02 2000-09-15 Weston Medical Ltd Verfahren zum füllen einer medizinkapsel und dabei erzeugter gegenstand
DE19638940C2 (de) * 1996-09-23 1999-01-07 Vetter & Co Apotheker Vorgefüllte Spritze für medizinische Zwecke
DE10102054A1 (de) * 2001-01-17 2002-08-01 Regine Sondermann Ampullenspritze
DE10144794A1 (de) * 2001-09-12 2003-03-27 Schott Glas Behälter zur nadellosen Injektion von medizinisch wirksamen Substanzen
TWI222370B (en) * 2001-12-14 2004-10-21 Roche Diagnostics Gmbh Needleless hypodermic injection device

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2005032625A1 *

Also Published As

Publication number Publication date
WO2005032625A1 (fr) 2005-04-14
DE10347379A1 (de) 2005-05-25

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